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HealthyPhase 1NCT02838264

A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers

A Phase 1 study testing PF-06463922 and Itraconazole in people with Healthy, run by Pfizer at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to estimate the effect of itraconazole on the single dose pharmacokinetics of PF-06463922 in healthy volunteers in the fasted state. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PF-06463922 and Itraconazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteBelgium
Study dates
16 Aug 2016to 3 May 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy female subjects of non childbearing potential and/or male subjects, who at the time of screening, are between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption.
  • A positive urine drug test.
  • History of HIV, Hep B or Hep C.
  • History of regular alcohol consumption.
  • Screening supine 12 lead ECG demonstrating PR interval >180 msec, QTc >450 msec or a QRS interval >120 msec.
Show all 9Show fewer
  • Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary: Use this criterion to describe any laboratory parameters that are not acceptable for the study. Examples included below:
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >1.0 × upper limit of normal (ULN);
  • Total bilirubin level >1.0 × ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <= ULN.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Pfizer Clinical Research Unit

    Brussels, B-1070

Other trials in Belgium

About this study

Official title: Phase 1, Open-label, Fixed Sequence, 2-period Study To Investigate The Effect Of Multiple Doses Of Itraconazole On The Pharmacokinetics Of Single Dose Pf-06463922 In Healthy Volunteers In The Fasted Condition

The purpose of this study is to estimate the effect of itraconazole on the single dose pharmacokinetics of PF-06463922 in healthy volunteers in the fasted state.

Read the detailed description

This will be a Phase 1, open-label, 2-period, fixed-sequence, crossover study to investigate the effect of the strong CYP3A inhibitor itraconazole on PF-06463922 PK in approximately 16 healthy volunteers. The study will consist of potentially up to 6 treatments: single dose of PF-06463922 50, 75 or 100 mg and PF-06463922 50, 75 or 100 mg in combination with multiple dose itraconazole.

Conditions
Healthy
Being tested
PF-06463922, Itraconazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06463922Drug

    Also called Lorlatinib

    Single oral dose of PF-06463922 50 mg on Day 1 of Period 1 and Day 5 of Period 2

  • PF-06463922Drug

    Also called Lorlatinib

    Single oral dose of PF-06463922 75 mg on Day 1 of Period 1 and Day 5 of Period 2

  • PF-06463922Drug

    Also called Lorlatinib

    Single oral dose of PF-06463922 100 mg on Day 1 of Period 1 and Day 5 of Period 2

  • PF-06463922Drug

    Also called Lorlatinib

    Highest safe single oral dose (mg) of PF-06463922 identified in the previous cohorts will be administered on Day 1 of Period 1 and Day 5 of Period 2

  • ItraconazoleDrug

    Also called Sporanox

    200 mg oral dose of itraconazole on Days 1 to 11 during Period 2

Study groups in NCT02838264
Study groupRoleWhat they receive
Cohort 1ExperimentalAll subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive PF-06463922 Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2.
Receives: Drug: PF-06463922; Drug: Itraconazole
Cohort 2ExperimentalAll subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive PF-06463922 Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2.
Receives: Drug: PF-06463922; Drug: Itraconazole
Cohort 3ExperimentalAll subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive PF-06463922 Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2.
Receives: Drug: PF-06463922; Drug: Itraconazole
Cohort 4ExperimentalAll subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive the highest safe dose (mg) of PF-06463922 as a single-dose Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2.
Receives: Drug: PF-06463922; Drug: Itraconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCinf for PF-06463922

    Area under the plasma concentration-time profile from time zero extrapolated to infinite time

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.

  2. Cmax for PF-06463922

    Maximum plasma concentration

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.

Secondary outcomes (14)

  1. AUClast for PF-06463922

    Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.

  2. Tmax for PF-06463922

    Time to Cmax

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and upto 168 hours post-dose.

  3. t1/2 for PF-06463922

    Terminal plasma elimination half-life

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.

  4. CL/F for PF-06463922

    Apparent clearance

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.

  5. Vz/F for PF-06463922

    Apparent volume of distribution

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.

  6. AUCinf for any potential PF-06463922 metabolite if necessary

    Area under the plasma concentration-time profile from time zero extrapolated to infinite time

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.

  7. AUClast for any potential PF-06463922 metabolite if necessary

    Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.

  8. Cmax for any potential PF-06463922 metabolite if appropriate

    Maximum plasma concentration

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.

  9. Tmax for any potential PF-06463922 metabolite if appropriate

    Time to Cmax

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.

  10. t1/2 for any potential metabolite of PF-06463922 if appropriate

    Terminal plasma elimination half-life

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.

  11. MRCmax for any potential PF-06463922 metabolite if appropriate

    metabolite to parent ratio for Cmax

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.

  12. MRAUClast for any potential PF-06463922 metabolite if appropriate

    metabolite to parent ratio for AUClast

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.

  13. MRAUCinf for any potential PF-06463922 metabolite if appropriate

    metabolite to parent ratio for AUCinf

    Measured: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.

  14. PR interval after PF-06463922 alone and after increased exposure of PF 06463922 (due to concomitant itraconzole administration).

    Change in PR interval from baseline after administration of PF-06463922 single dose as assessed by ECG.

    Measured: Within 24 hours after single dose administration of PF-06463922 alone and in combination with itraconazole.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2016 (estimated)
  2. Study start16 Aug 2016
  3. Primary completion31 Mar 2017
  4. Study completion3 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02838264
Sponsor's protocol ID
B7461012
Other IDs
2016-002386-57, ITRACONAZOLE DDI STUDY, 2016
Status last verified
May 2017
First submitted
17 Jul 2016
Last updated
15 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • Patel M, Chen J, McGrory S, O'Gorman M, Nepal S, Ginman K, Pithavala YK. The effect of itraconazole on the pharmacokinetics of lorlatinib: results of a phase I, open-label, crossover study in healthy participants. Invest New Drugs. 2020 Feb;38(1):131-139. doi: 10.1007/s10637-019-00872-7. Epub 2019 Nov 14.

    PubMed 31728714

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06463922 and Itraconazole in people with Healthy, run by Pfizer at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCinf for PF-06463922 (time frame: PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02838264, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.

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